Cleared Traditional

K961138 - ESORT II + 400 SERIES MONITOR

K961138 is an FDA 510(k) clearance for ESORT II + 400 SERIES MONITOR, manufactured by Medical Data Electronics. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K961138 · Medical Data Electronics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
264d
Days
Class 2
Risk

K961138 is an FDA 510(k) clearance for the ESORT II + 400 SERIES MONITOR. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on December 10, 1996 after a review of 264 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Data Electronics devices

FDA 510(k) Submission Details - K961138

510(k) Number K961138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1996
Decision Date December 10, 1996
Days to Decision 264 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 125d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 36
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K961138.
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
K000660 · Medical Data Electronics · Mar 2000
CARDIOSERV P
K962547 · Marquette Electronics, Inc. · Mar 1997
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
K963120 · Marquette Electronics, Inc. · Feb 1997
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000
K950856 · Zoll Medical Corp · Dec 1995
LIFEPAK 11
K951593 · Physio-Control Corp. · Dec 1995
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
K950483 · Hewlett-Packard Co. · May 1995